Renin Angiotensin
Conditions
Brief summary
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.
Interventions
DRUGFludrocortisone
50 µg of fludrocortisone per os
DRUGHydrocortisone
50 mg of intravenous hydrocortisone
Tablet of placebo of Fludrocortisone
2 ml of isotonic saline solution
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Men between 20 and 30 years * Body Mass Index between 18 kg/m² and 25 kg/m² * Normal clinical examination * Normal biological variables * Normal electrocardiogram and echocardiography * Written, voluntary informed consent * Non smoker since at least a year Non-inclusion Criteria: * Any history of significant allergy * Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function * Medication during the study * Alcohol consumption more than 30g/day or drug addiction * Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV. * Exclusion period mentioned on the Healthy Volunteers National list * Persons deprived of freedom or under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phenylephrine-mean arterial pressure dose-response relationship | Between 1.5 and 3 hours after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Humeral diameter and distensibility | Between administration time and 12 hours after treatment |
| Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances | Between administration time and 24 hours after treatment |
| Central aortic pressures, Augmentation Index (Aix) | Between administration time and 12 hours after treatment |
| Arterial stiffness: Carotid-femoral Pulse Wave Velocity | Between administration time and 12 hours after treatment |
| Plasma electrolytes, blood glucose, serum creatinine | Between administration time and 24 hours after treatment |
| Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations | Between administration time and 24 hours after treatment |
| Urinary electrolytes excretion | Between administration time and 24 hours after treatment |
Countries
France
Outcome results
None listed